Clinical trials

This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast, lung, or colon cancer. The study hypothesis is that participation in this exercise program improves tolerance to chemotherapy, allowing patients to receive more than 85% of the planned relative dose intensity. In addition, the program is expected to enhance treatment effectiveness by increasing the rate of complete radiological response. The main objective of the study is to assess the effectiveness of a supervised, multimodal therapeutic exercise program performed before and during chemotherapy in improving both treatment tolerance and treatment efficacy in patients with breast, lung, and colon cancer.

Background Lateral epicondylalgia is the most common cause of lateral elbow pain and affects approximately 1% to 3% of the population. It reduces strength, functionality, and quality of life, leading to limitations in work and daily activities and representing a relevant public health concern. Current scientific evidence suggests conservative physical therapy as the first-line treatment; however, heterogeneity exists among approaches, and clinical guidelines remain unclear. Rest and pharmacological treatment may provide short-term relief but do not resolve the underlying condition and may lead to recurrences. Therapeutic exercise has been shown to improve pain, strength, and function and is recommended as a first-line conservative intervention due to its favorable cost-benefit ratio. Thermotherapy and electrotherapy may also reduce pain and improve function compared with placebo. This study aims to evaluate the efficacy of the Super Inductive System (SIS) combined with a conventional physical therapy program. Hypothesis SIS therapy, combined with an upper extremity therapeutic exercise program and health education, will reduce pain, improve mobility and limb function, increase grip strength, facilitate return to activities of daily living (ADLs), and enhance perceived quality of life in individuals with lateral elbow tendinopathy. Objective To assess the effectiveness of SIS combined with therapeutic exercise and health education in adults aged 18 years and older with lateral elbow tendinopathy, compared with the application of SIS at a non therapeutic dose combined with conventional therapeutic exercise and health education. Methodology A prospective, experimental, randomized clinical trial will be conducted using a triple blind design (principal investigator, assessor, and participant). The study will include an intervention group (IG) (SIS at a therapeutic dose plus therapeutic exercise and health education) and a control group (CG) (SIS at a non therapeutic dose plus therapeutic exercise and health education). This multicenter study will take place at three Rehabilitation and Physical Therapy Services (Mataró, Sant Andreu-Barcelona, and Drassanes-Barcelona), all part of the Primary Care network of the Catalan Health Institute (ICS). Data collection will occur at baseline, post treatment, and at 3 and 6 month follow ups. Outcome measures will assess pain using the Visual Analog Scale (VAS) and algometry, mobility through goniometric evaluation, upper limb function using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), grip strength with dynamometry, health related quality of life with the EQ 5D 5L, and elbow specific pain and functional status using the Patient-Rated Tennis Elbow Evaluation (PRTEE). Inferential analyses will be performed for within group and between group comparisons. Data will be processed in accordance with current legislation. Data management will be performed using REDCap (Research Electronic Data Capture). Expected Outcomes A statistically significant improvement is expected in the intervention group compared with the control group. The use of SIS may contribute to reduced recovery time, fewer and shorter temporary work disabilities, and lower pharmaceutical costs among individuals with lateral epicondylalgia. Applicability and Relevance SIS is an innovative non invasive therapeutic technology that reduces acute and chronic pain, improves joint mobility, and promotes muscle strengthening in tendinopathies. Demonstrating its effectiveness and cost efficiency may support its incorporation into routine clinical practice, potentially reducing treatment duration, recovery time, and reliance on pharmacological therapy. This study will provide evidence to inform the implementation of SIS as an additional therapeutic tool in primary care physical therapy and rehabilitation settings.

Service-learning methodology (SL) combines training and community processes in a single project where participants are trained while working on real needs of the environment with the aim of improving it. This methodology enhances the professional skills of the students, their personal and competence development, and develops a deeper sense of civic responsibility. The Human Nutrition and Dietetics Degree (ND) of the Faculty of Health and Welfare Sciences (FCSB) of the University of Vic-Central University of Catalonia decided to incorporate this methodology, according to University's training model, with the aim of generating learning situations that allow them to act, reflect and solve problems based on significant learning. We applied SL in the subject of Food Education Strategies designing and implementing a small food education program with 1 contact to detect the needs of the users, and 3 educational sessions. The implementation of the SL is based on the SL guide proposed by the Service Learning Network of Catalan Universities and we make it with 4 local social entities. The teacher responsible for the SL is coordinated with responsibles from entities who act as facilitators, authorizing the collection of data from the people of the entities, recruiting, informing and collecting the willingness to participate from the users. We plan to study the experience of participating in the SL activity in terms of student acquisition of skills and satisfaction of all the parties involved, based on an observational study carried out during 4 academic years (2025-2029). Through convenience sampling, a participation of 65 people is expected (20 students, 40 users, 5 responsible from entities). Data collection plans to compile information on: a.Experience of the SL of the university student body. b. Assessments of the users and responsibles from entities on the impact, quality and satisfaction with the SL activity. c. Proposal for improving the SL activity with the entities using the rubric for self-assessment and improvement of SL projects. Data collection will take place at the end of the activity using the REDCap platform (Research Electronic Data Capture) and the statistic analysis is planned using the SPSS statistical program.

Unilateral spatial neglect (USN) is a common and highly disabling condition following acquired brain injury (ABI), significantly impairing individuals' ability to perform daily activities and reducing their autonomy. It frequently affects patients who have suffered a stroke or traumatic brain injury, and it is often associated with worse functional outcomes and increased care needs. Despite advances in neurorehabilitation, conventional assessment and treatment tools for USN have shown limitations in sensitivity and ecological validity. Immersive Functional Virtual Reality (IFVR) is an emerging and promising technology that creates controlled, interactive environments, facilitating both assessment and rehabilitation in a motivating and safe way. The REVINE study explores the feasibility, usability, and preliminary clinical effects of an immersive VR-based intervention tailored to address motor and spatial deficits in adults with ABI and USN. This is a prospective, non-controlled feasibility study using a single-group interrupted time series design. Participants (N=30) will be recruited from two neurorehabilitation services in Catalonia (Spain): the Neurological Rehabilitation and Brain Injury Unit at Vall d'Hebron University Hospital and the Outpatient Rehabilitation Service at Consorci Hospitalari de Vic. Eligible participants will be adults with ABI in the subacute or chronic phase, presenting USN (as measured by the Catherine Bergego Scale and the Bells Cancellation Test) and mild-to-moderate upper limb impairment. The intervention consists of 12 supervised individual IFVR sessions (30 minutes/session, 3 times/week for 4 weeks), using the KINESIX system (NeuroGroup XR Inc., Montreal, Canada). A progressive series of gamified tasks will be delivered through immersive VR, targeting spatial exploration and upper limb function, with adjustable difficulty and real-time feedback. Participants will undergo three pre-intervention and three post-intervention evaluations, spaced one month apart. Clinical outcomes include the degree of USN (measured by the Catherine Bergego Scale, the Bells Cancellation Test, and the KINESIX light-reaching test), usability (System Usability Scale), and satisfaction (User Satisfaction Evaluation Questionnaire). Feasibility outcomes include recruitment and retention rates, adherence to treatment, session completion times, adverse events, and therapist assistance level. We hypothesize that IFVR will be a viable and well-accepted intervention, with high user satisfaction, minimal adverse effects, and measurable improvements in neglect-related outcomes. This study aims to inform the future design of larger-scale trials and support the integration of IFVR into routine neurorehabilitation settings or home-based telerehabilitation programs.

KOKU Bladder aims to develop and test an evidence based digital health program with behavior change techniques to improve bladder health of adults aged 50 and over. A novel module embedded in the approved app "Keep-on-Keep-up" (KOKU) will be co-created with end-users, researchers, health professionals, and stakeholders through a participatory and appreciative action and reflection methodology. After a comprehensive literature review and consultation with 4-6 experts, 6 focus groups will be undertaken in Kaunas(Lithuanian), Catalonia (Spain) and Manchester (UK) to co-create the contents of the module. Data will be analyzed using thematic analysis. Gamification and the Honeycomb model for user experience will be followed to achieve an appropriate technological solution that will be tested through a randomized controlled trial with at least 120 individuals. A mixed methods approach (quantitative/qualitative analysis) will be used to assess the feasibility and acceptability of the program. Open data and science, gender and ethical aspects, as well as a risk management plan are considered. A plan for communication, dissemination, exploitation of results will be considered. KOKU Bladder will be highly scalable and will have wide reach and impact. This proposal is in line with EU policy initiatives on Active and Healthy Ageing (bladder health and continence will be promoted), targeting aspects such as eHealth, Innovation and Digital Care Transformation, by supporting users to demand more responsive and integrated care programs for chronic conditions and enhancing self-management strategies, independence and health intelligence.

The GEROS Project aims to develop and implement a Service-Learning (S-L) program that integrates Comprehensive Geriatric Assessment (CGA) and health promotion, for students at the Faculty of Health Sciences and Welfare at the University of Vic - Central University of Catalonia (UVic-UCC). This initiative engages university students, healthcare professionals, and older adults (60+) in a participatory, intergenerational approach that fosters mutual learning and community engagement. The study follows a non-experimental mixed-method design, involving students from Nursing, Physiotherapy, Human Nutrition and Dietetics, Occupational Therapy, and Psychology. Participants include older adults (60+) who can independently travel to the university. The project is integrated into different subjects, in groups of 4-5 students, participants conduct a Comprehensive Geriatric Assessment (CGA), evaluating frailty using VIG-Frail, intrinsic capacity with ICOPE, quality of life with EUROQOL 5D-5L, and specific health indicators with Nursing Outcomes Classification (NOC). To assess the program's effectiveness, several outcome measures will be analyzed including students' perceived knowledge, competencies, and skills, as well as older adults' awareness of their health status, lifestyle, and risk factors. Additionally, the satisfaction levels of both will be evaluated. The items will be evaluated using a 1-5 Likert Scale, and the analysis will be conducted with SPSS. Data recording will be carried out through REDCap. The GEROS Project aligns with the United Nations' Sustainable Development Goals (SDGs), specifically SDG 3 (Good Health and Well-being) and SDG 10 (Reduced Inequalities). By offering care to the aging population and providing them with personalized health recommendations, the project promotes preventive strategies, active aging, and intergenerational learning. Furthermore, GEROS integrates innovative educational methodologies, encouraging experiential learning, collaboration with healthcare professionals, and the development of practical skills in real-world contexts. The program's scalability and adaptability could serve as a model for other universities and healthcare institutions aiming to enhance geriatric care through service-learning initiatives.

Background and Justification Childhood developmental disorders, such as Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and Developmental Coordination Disorder (DCD), pose significant challenges for children and their families. These disorders impact children's growth and learning, leading to difficulties in key areas such as language, communication, behavior, social interaction, and motor skills. Research in this area is limited, particularly regarding fine and gross motor skills in relation to sensory processing in children with these diagnoses. Hypothesis and Objectives There is an association between motor skills and sensory processing in children aged 4 to 11 years, depending on whether they have typical or atypical neurodevelopment, such as ASD, ADHD, and DCD. Main Objective: To evaluate the association between motor skills and sensory processing in children aged 4 to 11 years with either typical or atypical neurodevelopment (e.g., ASD, ADHD, and DCD). Secondary Objectives: To describe and compare motor skills among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD. To describe and compare sensory processing among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD. Methodology The study is a cross-sectional observational case-control study. Participants are users of the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, or Criv in Vic. The sample will include 30 children as controls (typical neurodevelopment) and 10 children as cases (atypical neurodevelopment: ASD, ADHD, DCD). Children will be assessed using the Infant Motor Profile (IMP) to measure motor development and the Short Sensory Profile-2 (SSP-2) to evaluate sensory processing. Statistical Analysis Quantitative variables will be described using means and standard deviations, while categorical variables will be presented as frequencies and percentages. Statistical tests such as the Student's t-test will be used to compare means between two groups, ANOVA for comparisons among more than two groups, and the Chi-square test to analyze associations between categorical variables. Expected Results The study is expected to provide essential insights into the differences in motor development between children with typical and atypical neurodevelopment, as well as the relationship between biological and external factors and these differences. These findings could help improve clinical and educational interventions for these children by tailoring them to their specific needs, thereby enhancing their overall well-being and development. Ethical Considerations The study protocol will be submitted to the Research Ethics Committee (CER) of UVic-UCC, adhering to good clinical practice guidelines in accordance with the Declaration of Helsinki. Participants will be assigned a code to ensure data pseudonymization, with data securely stored on the Microsoft 365 server of UVic-UCC. Participants will have the right to withdraw from the study at any time, and personal data will be deleted once the study is completed. Researchers will ensure confidentiality as dictated by Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights, Regulation (EU) 2016/679 of April 27, 2016, on data protection, and complementary regulations, as well as Organic Law 1/1982 of May 5 on the right to honor, personal and family privacy, and self-image.